Medication info
Nizatidine Capsule 150mg (Nizatidine)

Nizatidine Capsule 150mg (Nizatidine)

Prescription medicationHard capsuleOral
Ingredient · strength
Nizatidine›150mg / 1 capsule
Manufacturer / importer
White Life Science Co., Ltd.
Appearance
Hard capsule filled with a white to off-white powder, with a yellow upper part and a light yellow lower part
Packaging
30 capsules/bottle, 100 capsules/bottle
Approval status
Active

MFDS item code 201600879 · Approved 2016.02.16 · Insurance code 625201180

Summary

Main use
Treatment of ulcers·prevention of duodenal ulcer recurrence, treatment of esophagitis·heartburn, improvement of gastric mucosal lesions
Who takes it
Adults
Adult dose
1. Treatment of active gastric and duodenal ulcers Adults: Administer nizatidine 300mg once daily at bedtime, or 150mg per dose twice daily, orally in the morning and evening. Most ulcers heal within 4 weeks, but treatment may be continued for up to 8 weeks if necessary. In cases of active gastric ulcer, malignancy must be ruled out before treatment. 2. Prevention of recurrence of duodenal ulcers Adults: After healing of a duodenal ulcer, administer 150mg orally once daily at bedtime. Treatment may continue for up to 1 year; results of longer-term administration are unknown. 3. Gastroesophageal reflux disease Adults: Administer 150mg per dose orally twice daily, in the morning and evening. Treatment may continue for up to 12 weeks. 4. Improvement of gastric mucosal lesions Adults: Administer 150mg per dose orally twice daily, in the morning and evening, for 2 weeks. 5. Dose adjustment for patients with severe renal impairment The dose for patients with renal impairment should be reduced and adjusted as follows. Creatinine clearance Dose Active duodenal ulcer Gastroesophageal reflux disease (GERD) Benign gastric ulcer 20~50 ml/min 150mg daily < 20 ml/min 150mg every other day Maintenance therapy 20~50 ml/min 150mg every other day < 20 ml/min 150mg every 3 days Creatinine clearance may be below 50mL/min in some elderly patients. Based on pharmacokinetic data in patients with renal impairment, the dose should also be reduced according to the degree of renal impairment in such patients. The clinical impact of this dose reduction in patients with renal impairment has not been evaluated.

Ingredients

Manufacturer
White Life Science Co., Ltd.

Efficacy & effects

Treatment of ulcers·prevention of duodenal ulcer recurrence, treatment of esophagitis·heartburn, improvement of gastric mucosal lesions

  • Active gastric ulcer
  • duodenal ulcer
  • recurrence of duodenal ulcer
  • erosive esophagitis
  • ulcerative esophagitis
  • heartburn
  • gastric mucosal lesions
  • acute gastritis
  • acute exacerbation of chronic gastritis
View approved original text

This medicine is used to treat active gastric and duodenal ulcers and prevents the recurrence of duodenal ulcers. It also alleviates symptoms of heartburn due to erosive and ulcerative esophagitis diagnosed by endoscopy and gastroesophageal reflux disease. Additionally, it has effects on improving lesions such as erosion, bleeding, redness, and swelling of the gastric mucosa that appear during acute exacerbations of acute and chronic gastritis. Therefore, this medication is very useful for treating various inflammatory diseases and ulcers of the stomach and esophagus. It is used to improve overall gastrointestinal symptoms and enhance patients' quality of life.

How to take

Adult dose

1. Treatment of active gastric and duodenal ulcers Adults: Administer nizatidine 300mg once daily at bedtime, or 150mg per dose twice daily, orally in the morning and evening. Most ulcers heal within 4 weeks, but treatment may be continued for up to 8 weeks if necessary. In cases of active gastric ulcer, malignancy must be ruled out before treatment. 2. Prevention of recurrence of duodenal ulcers Adults: After healing of a duodenal ulcer, administer 150mg orally once daily at bedtime. Treatment may continue for up to 1 year; results of longer-term administration are unknown. 3. Gastroesophageal reflux disease Adults: Administer 150mg per dose orally twice daily, in the morning and evening. Treatment may continue for up to 12 weeks. 4. Improvement of gastric mucosal lesions Adults: Administer 150mg per dose orally twice daily, in the morning and evening, for 2 weeks. 5. Dose adjustment for patients with severe renal impairment The dose for patients with renal impairment should be reduced and adjusted as follows. Creatinine clearance Dose Active duodenal ulcer Gastroesophageal reflux disease (GERD) Benign gastric ulcer 20~50 ml/min 150mg daily < 20 ml/min 150mg every other day Maintenance therapy 20~50 ml/min 150mg every other day < 20 ml/min 150mg every 3 days Creatinine clearance may be below 50mL/min in some elderly patients. Based on pharmacokinetic data in patients with renal impairment, the dose should also be reduced according to the degree of renal impairment in such patients. The clinical impact of this dose reduction in patients with renal impairment has not been evaluated.

Precautions

This medication should not be used in certain patients. Those who are allergic to this drug or similar medications should not take it. Patients with genetic disorders affecting lactose breakdown should also avoid taking this drug. This medication should be used cautiously in some patients. Those with a history of drug allergies should consult a doctor before taking it. Patients with liver function problems should use caution, and those with impaired kidney function may require dose adjustments to avoid increased drug concentrations. Rarely, hypersensitivity reactions such as skin rashes, itching, and shortness of breath may occur when taking this medication. Anemia or abnormal blood cell counts may arise, so notify medical staff immediately if any unusual symptoms occur. Gastrointestinal symptoms like constipation, diarrhea, dry mouth, and nausea may also manifest. Liver function abnormalities have also been reported, and symptoms of hepatitis or jaundice may appear, so caution is advised. Mental confusion, headache, drowsiness, and dizziness can rarely occur. Rapid heartbeat may also occur. In females, breast enlargement may rarely occur, while in males, erectile dysfunction or reduced libido has been reported. Skin abnormalities such as rashes or hives may also occur. This drug can mask symptoms of gastric cancer, so it should only be used after confirming that there is no malignant disease. As it is excreted through the kidneys, patients with reduced kidney function should reduce the dose and monitor treatment efficacy and side effects carefully. Pregnant or nursing women should use this medication only when absolutely necessary, as its safety has not been established. The safety in pediatrics has not been established, and elderly patients are at higher risk of renal function impairment and should have kidney function testing before administration. There is a low potential for drug interactions with this medication, but caution is needed when used with high doses of aspirin. In cases of overdose, symptoms may include vomiting, diarrhea, and pupil constriction, and since there is no specific antidote, treatment should follow the directives of medical staff. This medication is known to have a low carcinogenic potential with long-term high-dose use; however, there is a risk of side effects such as liver function abnormalities, so caution is necessary.

Side effects

  • Rash
  • itching
  • bronchial asthma
  • laryngeal edema
  • anaphylactic symptoms
  • anemia
  • leukopenia
  • increased neutrophils
  • thrombocytopenic purpura
  • constipation
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  • diarrhea
  • dry mouth
  • nausea
  • elevated GOT
  • elevated GPT
  • elevated AL-P
  • hepatitis
  • jaundice
  • cholestatic liver damage
  • hepatocellular liver damage
  • mental confusion
  • headache
  • drowsiness
  • dizziness
  • weakness
  • seizures
  • asymptomatic ventricular tachycardia
  • gynecomastia
  • sweating
  • urticaria
  • exfoliative dermatitis
  • vasculitis
  • hyperuricemia
  • fever
  • chest pain
  • myalgia
  • rhinitis
  • pharyngitis
  • cough

Not everyone experiences these, and they can vary from person to person.

Storage

Keep this medication in a tightly closed container to avoid exposure to air, and it is advisable to store it at room temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the drug's efficacy and ensure safe use.

Appearance and packaging

Appearance

Hard capsule filled with a white to off-white powder, with a yellow upper part and a light yellow lower part

Package unit

30 capsules/bottle, 100 capsules/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.